|By ACN Newswire||
|November 7, 2012 04:30 AM EST||
New York, NY, Nov 7, 2012 - (ACN Newswire) - Medical device manufacturers can improve compliance with the Food and Drug Administration (FDA) by better communication and understanding of the regulations from the start. Setting product development goals at this stage will also improve the end product and reduce costs, says Tom Black, Vice President, Original Equipment Manufacturer & International Divisions Sales and Marketing, B. Braun Medical Inc. Complete alignment of the customer and the FDA's requirements needs will allow for innovative products to follow a smoother path, he adds.
A speaker at the upcoming marcus evans Medical Device Manufacturing Summit Fall 2012 and the Medical Device R&D Summit Fall 2012, in Colorado Springs, Colorado, November 27-28, Black talks about the difficulties facing the industry at the moment and how new manufacturing methods can help remedy these setbacks.
- What difficulties are there within the medical device manufacturing industry?
The current challenges lie in providing customers with affordable products while meeting all of the new documentation requirements. An example of this is all of the new material control information that is being requested. Outsourcing partners are also feeling the pressure of delivering documentation and support that require resources that are costly. These additional costs must be offset by continuous focus on improving manufacturing processes.
People within the industry are continuously searching for new methods to improve patient safety with new products or processes. An organization can take advantage of this by being prepared for new ideas and having a culture that continuously looks for improvement. This focus throughout an organization will enable new products to be developed and placed into the market. New opportunities will be driven even further if the focus is on better outcomes that also lead to lower overall healthcare costs.
- How can medical device manufacturers comply with FDA requirements?
The process of compliance can be improved by improving communications with the FDA in order to obtain a clear understanding of their requirements upfront. This will save time and costs, by avoiding any misunderstanding before the development of new products and new processes.
This communication process can then be carried forward into innovation. If we understand what is required from a patient safety, cost and practitioner standpoint, then research can be done into what products customers want. This can then be aligned with the manufacturing capabilities of the organization, thus better and more innovative products will be produced.
- What advice can you give for developing excellence with quality assurance systems?
First, define the objectives of the organization, and continue to focus on quality. There must be a holistic culture of understanding that quality and continuous improvement are the first priority. The most innovative and adaptable companies who continue to focus on quality and efficiency will succeed.
For more information please send an email to [email protected] or visit the event websites below:
Medical Device R&D Summit Fall 2012:
marcus evans group - manufacturing sector portal - http://tiny.cc/FWbg2b
Please note that the Summit is a closed business event and the number of participants strictly limited.
About marcus evans Summits
marcus evans Summits are high level business forums for the world's leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com.
- Twitter: www.twitter.com/meSummitsGlobal
- YouTube: www.youtube.com/user/MarcusEvansGroup
- SlideShare: www.slideshare.net/MarcusEvansSummits
Source: marcus evans Summits
Maria Gregoriou, Journalist, marcus evans, Summits Division Tel: +357 22 849 400 Email: [email protected]
Copyright 2012 ACN Newswire. All rights reserved.
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Ben Perlmutter, a Sales Engineer with IBM Cloudant, demonstrated techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, faster user e...
Nov. 24, 2015 07:30 PM EST Reads: 330
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Nov. 24, 2015 06:00 PM EST Reads: 315
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
Nov. 24, 2015 06:00 PM EST Reads: 365
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Nov. 24, 2015 05:30 PM EST Reads: 138
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 24, 2015 04:30 PM EST Reads: 283
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 24, 2015 03:45 PM EST
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Nov. 24, 2015 03:30 PM EST Reads: 459
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 24, 2015 03:30 PM EST Reads: 133
There are over 120 breakout sessions in all, with Keynotes, General Sessions, and Power Panels adding to three days of incredibly rich presentations and content. Join @ThingsExpo conference chair Roger Strukhoff (@IoT2040), June 7-9, 2016 in New York City, for three days of intense 'Internet of Things' discussion and focus, including Big Data's indespensable role in IoT, Smart Grids and Industrial Internet of Things, Wearables and Consumer IoT, as well as (new) IoT's use in Vertical Markets.
Nov. 24, 2015 03:30 PM EST Reads: 507
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
Nov. 24, 2015 03:00 PM EST Reads: 403
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application del...
Nov. 24, 2015 03:00 PM EST Reads: 283
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Nov. 24, 2015 02:15 PM EST Reads: 257
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Nov. 24, 2015 02:00 PM EST Reads: 416
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 24, 2015 01:45 PM EST Reads: 405
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 24, 2015 01:45 PM EST Reads: 335